System and method of manipulating spinal constructs

ABSTRACT

Systems of manipulating (e.g., compressing or distracting) a spinal construct are provided herein. In general, the system can include a surgical sleeve extending from a vertebra and a fulcrum movably coupled to some component of the system thereby allowing the fulcrum to be positioned at various location along the length of the sleeve. As indicated, the fulcrum can be movably coupled to virtually any component of the system. For example, the fulcrum can be movably coupled to the surgical sleeve, to a manipulation device sized and configured to receive the surgical sleeve, to a driver configured to apply a manipulation force, etc. Additionally, methods for manipulating a spinal construct are also provided herein.

FIELD OF USE

The present disclosure relates to systems and methods of manipulatingspinal constructs, in particular to systems and methods of compressingor distracting such constructs.

BACKGROUND

For numerous reasons, spinal fixation devices are used in spinal surgeryto align and/or fix a desired relationship between adjacent vertebralbodies. Such devices typically include a spinal fixation element, suchas a relatively rigid fixation rod or plate, that is coupled to adjacentvertebrae by attaching the element to various anchoring devices, such ashooks, bolts, wires, or screws. The fixation element can have apredetermined contour that has been designed according to the propertiesof the target implantation site, and once installed, the fixationelement can hold the vertebrae in a desired spatial relationship, eitheruntil desired healing or spinal fusion has taken place, or for somelonger period of time.

In use, a spinal fixation element can be anchored to specific portionsof a vertebra. Since each vertebra varies in shape and size, a varietyof anchoring devices have been developed to facilitate engagement of aparticular portion of the bone. Pedicle screw assemblies, for example,have a shape and size that is configured to engage pedicle bone. Suchscrew assemblies typically include a threaded shank capable of beingpositioned within a vertebra, and a head portion having a rod-receivingelement, usually in the form of a U-shaped recess. A set-screw, plug, orsimilar type of closure mechanism can be used to secure the fixationelement, e.g., a spinal rod, into the rod-receiving head of the pediclescrew.

Often, such fixation procedures will require some degree of manipulationof adjacent vertebrae (e.g., compression or distraction) in order toproperly position the fixation element and/or to achieve the desiredtherapeutic effect. However, these manipulation steps can be cumbersomeas the working area tends to be crowded and the required instrumentationcan be difficult to position, adjust, and/or maintain at a desiredlocation. Thus, there remains a need for systems and methods ofmanipulating spinal constructs.

SUMMARY

Systems and methods of manipulating (e.g., distracting or compressing) aspinal construct are provided herein. More specifically, the presentlydisclosed systems and methods simplify a surgeon's ability to manipulatespinal construct(s) by providing an adjustable fulcrum disposed betweenfirst and second surgical sleeves (e.g., percutaneous access devices)extending from adjacent vertebrae. As described below, variousembodiments of such a fulcrum can be movably coupled to any of a numberof components. For example, the fulcrum can be coupled to either of thesurgical sleeves extending from the adjacent vertebrae or the fulcrumcan be coupled to a manipulation device configured for placement oversuch a surgical sleeve. In another example, the fulcrum can be coupledto a manipulation instrument capable of applying a desired manipulationforce either above or below the secured fulcrum thereby resulting indistraction or compression of the spinal construct, respectively. Inother embodiments, the system can include additional sleeves (e.g., ananti-torque sleeve) capable of further simplifying the procedure. Thesystem can also be configured to allow for various constraints of apatient's anatomy (e.g., close spacing between vertebrae) whileperforming such a procedure. Other such benefits and advantages of thepresently disclosed system and method will be evident from the followingdisclosure.

Various aspects of a system for manipulating a spinal construct areprovided herein. In one aspect, a spinal manipulation system is providedwhich can include a sleeve having a proximal end, a distal end, and aninner lumen extending therebetween. Further, the system can include afulcrum releasably coupled to the sleeve such that the fulcrum can beselectively positioned at a desired level on the sleeve. Variousembodiments of such a sleeve are included within the scope of thepresently disclosed system. For example, the sleeve can be any type ofsurgical sleeve (e.g., a percutaneous access device) having a distal endconfigured to engage a bone anchor positioned within a vertebra. Inother embodiments, the sleeve can be a manipulation device having aninner lumen sized and configured to receive such a surgical sleeve.

Various embodiments of such a manipulation device are provided herein.For example, the manipulation device can have a distal end having anindentation configured to receive a spinal fixation element formed inthe outer surface of the device. In other embodiments, the manipulationdevice can include a proximal end which is configured to releasablyengage a proximal end of a surgical sleeve. In such an embodiment, theproximal end of the device can further include at least one flat regioncorresponding to a flat region formed on the proximal end of thesurgical sleeve. Thus, the distal indentation and/or the proximal flatregion can prevent rotation/twisting of the manipulation device relativeto the surgical sleeve.

The system can also include a fulcrum capable of being positioned at anyof a plurality of locations relative to first and second surgicalsleeves extending from adjacent vertebrae. As described below, thefulcrum can be virtually any element capable of providing the desiredtherapeutic effect. For example, the fulcrum can be a substantiallycylindrical element having first and second ends with a longitudinalaxis extending therebetween. In such an example, the fulcrum can becoupled to the sleeve such that the longitudinal axis of the fulcrum issubstantially perpendicular to a longitudinal axis of the surgicalsleeve. Additionally, the fulcrum can include a first actuator coupledto the first end and (optionally) a second actuator coupled to thesecond end wherein the first and second actuators are biased (e.g., viaa spring) such that in the absence of an actuation force the fulcrum canremain securely engaged to a desired location (e.g., engagement point)of the sleeve. The fulcrum can be sized to allow at least one ofadjacent surgical sleeves to pivot about the fulcrum in response to amanipulation force. In some embodiments, the diameter of the fulcrum canbe increased as required by the given procedure and/or the patient'sanatomy. For instance, in one such embodiment, any of a plurality ofinserts can be secured to the fulcrum thereby increasing the diameter adesired amount.

As described below, the fulcrum can be movably coupled to the sleeve invarious manners. For example, in one embodiment, the sleeve (e.g., anytype of surgical sleeve or a manipulation device sized and configured toreceive the surgical sleeve) can include a plurality of engagementpoints configured to releasably engage the fulcrum extending along alength of the sleeve. In another embodiment, the fulcrum can bereleasably engaged to a cap configured to be positioned over a proximalend of the surgical sleeve. As will be shown, the cap can extend anydesired length along the surgical sleeve thereby positioning the fulcrumat any desired location relative to the adjacent surgical sleeves. Inone embodiment, a kit can also be provided which can include a pluralityof such caps having various lengths.

In other embodiments, the system can include various additional types ofaccessory sleeves capable of providing additional therapeutic effects.For example, the system can include an anti-torque sleeve coupled to asecond surgical sleeve located adjacent the first surgical sleeve. In anexemplary embodiment, the anti-torque sleeve can include a proximal end,a distal end, and an inner lumen extending therebetween wherein theinner lumen of the sleeve is sized and configured to receive the secondsurgical sleeve (e.g., a second percutaneous access device). In such anembodiment, the anti-torque sleeve (optionally having a handle extendingtherefrom) can facilitate delivery of a closure mechanism (e.g., a setscrew, a plug, or a pin) to a bone anchor corresponding to the secondsurgical sleeve. Thus, use of the anti-torque sleeve can allow for thefixation element to be secured almost immediately following thecompression or distraction procedure.

In another aspect, a spinal manipulation system is provided whichincludes a first surgical sleeve extending from a first vertebra, asecond surgical sleeve extending from a second vertebra, and a driverconfigured to supply a manipulation force to the adjacent surgicalsleeves. Further, the system can include a fulcrum movably coupled toany of the first or second surgical sleeves, or the fulcrum can bemovably coupled to the driver. In any of these examples, the fulcrum canbe selectively positioned at a desired level relative to the first andsecond surgical sleeves. When the fulcrum is movably coupled to thedriver, the fulcrum can be adjusted between an extended position distalof a pair of forceps of the driver, and a retracted position proximal ofthe pair of forceps. Thus, the surgeon can adjust the relative positionof the fulcrum to the forceps depending on the desired manipulation(e.g., compression or distraction). In another embodiment, similar toabove, the fulcrum can be coupled to a cap releasably positioned over aproximal end of one of the surgical sleeves. Also similar to above, thesystem can include a manipulation device having a proximal end, a distalend, and an inner lumen extending therebetween wherein the inner lumenis sized and configured to receive either of the surgical sleeves.Additionally, the manipulation sleeve can include a plurality ofengagement points configured to releasably engage the fulcrum extendingalong a length thereof.

In yet another aspect, a spinal manipulation system is provided whichincludes an elongate sleeve having a proximal end, a distal end, and aninner lumen extending therebetween wherein the inner lumen is sized andconfigured to be positioned over a surgical sleeve. Additionally, theelongate sleeve can include an engagement track having a plurality ofengagement points formed at distinct locations along a length of thesleeve. The system can also include a fulcrum configured to releasablyengage any of the plurality of the engagement points. Like above, thefulcrum can be slidably coupled to the engagement track.

Various aspects of a method for manipulating a spinal construct are alsoprovided herein. In one aspect, the method includes engaging a firstsurgical sleeve to a first bone anchor disposed within a first vertebraand engaging a second surgical sleeve to a second bone anchor disposedwithin a second vertebra located adjacent the first vertebra. Next, themethod can include installing a spinal fixation element such that atleast a portion of the fixation element resides within the first andsecond bone anchors. The method further includes applying a manipulationforce to the first and second surgical sleeves by a driver. As detailedbelow, the manipulation force can pivot one of the surgical sleevesaround the fulcrum which, similar to the embodiments summarized above,can be movably coupled with any of the first surgical sleeve, the secondsurgical sleeve, a manipulation device, or a driver.

As described below, the location of the fulcrum relative to the locationof the applied manipulation force can be adjusted to effect compressionor distraction and also the amount of compression or distraction soprovided. For example, in one embodiment, the manipulation force can beapplied above the fulcrum to effect distraction of a spinal construct,while in other embodiments the manipulation force can be applied belowthe fulcrum to effect compression of the construct. Additionally, thedistance above or below the fulcrum to which the force is applied candetermine the amount of force provided. Also like above, the method caninclude coupling a manipulation device to the first surgical sleevewherein the fulcrum is movably coupled to the manipulation device.Additionally, the method can further include coupling an anti-torquesleeve to the second surgical sleeve. As described below, the use ofsuch an anti-torque sleeve can allow for a closure mechanism (e.g., aset screw, a plug, or a pin) to be almost immediately secured to thecorresponding bone anchor.

In yet another embodiment, a method is provided for manipulating aspinal construct which includes engaging a surgical sleeve to a firstvertebra and engaging a second surgical sleeve to a second vertebraadjacent to the first vertebra. The method can further include placingat least a portion of a spinal fixation element within first and secondbone anchors coupled to the first and second surgical sleeves,respectively. The method can also include positioning a manipulationdevice over the first surgical sleeve. In such an embodiment, themanipulation sleeve can include a fulcrum movably (e.g., slidably)coupled thereto. Like above, such a movable coupling can allow thefulcrum to releasably engage any of a plurality of engagement pointsalong an engagement track of the device. The method can also includesecuring a closure mechanism to the first bone anchor thereby securingthe spinal fixation element therein. Optionally, the method can includecoupling an accessory sleeve (e.g., an anti-torque sleeve) to anadjacent surgical sleeve. The method can also include releasablyengaging the fulcrum to a desired engagement point along the length ofthe engagement track and applying a manipulation force to the adjacentsleeves. In such an embodiment, the manipulation force is capable ofcausing the second surgical sleeve to pivot about the fulcrum. Themethod can further include securing a second closure mechanism to thesecond bone anchor thereby securing the spinal fixation element withinthe second bone anchor.

In other embodiments, the method can include removing the manipulationdevice from the first surgical sleeve and removing the anti-torquesleeve from the second percutaneous access device. Further, the methodcan include repositioning the manipulation device over the secondsurgical sleeve and positioning the anti-torque sleeve over a thirdsurgical sleeve having a distal portion engaged to a third bone anchor.Thus, the method can include applying a second manipulation force to therepositioned manipulation device and anti-torque sleeve thereby causingthe anti-torque sleeve to once again pivot about the fulcrum.Additionally, the method can include engaging a third closure mechanismto the third bone anchor thereby securing the spinal fixation elementwithin the third bone anchor. These steps (or at least some of them) canbe repeated as many times as desired thereby effecting compression ordistraction to any number of spinal constructs along a patient's aspinal column.

These aspects, as well as others, are described in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed systems and methods will be more fullyunderstood from the following detailed description taken in conjunctionwith the accompanying drawings, in which:

FIG. 1A is a perspective view of an exemplary embodiment of amanipulation device;

FIG. 1B is a front exploded view of the manipulation device of FIG. 1A;

FIG. 1C is a rear exploded view of the manipulation device FIG. 1A;

FIG. 2A is a perspective view of a manipulation device and an embodimentof an anti-torque sleeve prior to placement over first and secondsurgical sleeves;

FIG. 2B is a perspective view of the embodiment of FIG. 2A wherein themanipulation device and the anti-torque sleeve are positioned overrespective surgical sleeves;

FIG. 2C is a perspective view of the embodiment of FIG. 2A wherein thefulcrum is positioned at a proximal location of the manipulation device;

FIG. 2D is a perspective view of the embodiment of FIG. 2A illustratinga driver applying a compression force to the adjacent surgical sleeves;

FIG. 2E is another perspective view of the embodiment of FIG. 2A showingcompression of the spinal construct resulting from the compressionforce;

FIG. 3A is a perspective view of an embodiment illustrating adistraction force being applied to adjacent surgical sleeves;

FIG. 3B is a perspective view of the embodiment of FIG. 3A showingdistraction of a spinal construct resulting from the distraction force;

FIG. 4A is a perspective view of an embodiment wherein an insert iscoupled to a fulcrum;

FIG. 4B is a perspective view of the embodiment of FIG. 4A showing theinsert disengaged from the fulcrum;

FIG. 4C is a perspective view of an embodiment of the insert of FIG. 4A;

FIG. 5A is a perspective view of another exemplary embodiment of afulcrum element having a fulcrum releasably coupled to a cap;

FIG. 5B is a perspective view of the fulcrum of the embodiment of FIG.5A;

FIG. 5C is a perspective view of the cap of the embodiment of FIG. 5A;

FIG. 6A is a perspective view of another exemplary embodiment wherein afulcrum is movably coupled to a driver wherein the fulcrum is shown inan extended position;

FIG. 6B is a perspective view of the embodiment of FIG. 6A wherein thefulcrum is shown in a retracted position; and

FIG. 6C is a rear view of the embodiment of the driver of FIG. 6A.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the systems and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the systems andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present disclosure is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present disclosure.

Various embodiments of a system of manipulating (e.g., compressing ordistracting) a spinal construct are provided herein. In general, thepresently disclosed system utilizes first and second surgical sleevesextending from adjacent vertebrae and a fulcrum that isposition-adjustable and releasably engaged to some component of thesystem to allow one of the sleeves to pivot about the fulcrum inresponse to the application of a manipulation force. For example, thefulcrum can be adjusted to a desired position and releasably coupled toeither of the surgical sleeves, releasably coupled to a manipulationdevice positioned over one of the surgical sleeves, or the fulcrum canbe movably coupled to a driver capable of applying the manipulationforce to the sleeves. The system can also include additional accessorysleeves (e.g., an anti-torque sleeve) that are configured to be coupledto one of the surgical sleeves. As described below, the accessory sleevecan enhance the efficiency of the system and/or provide some additionaltherapeutic benefit.

As stated, the system can include or work in conjunction with first andsecond surgical sleeves extending from adjacent vertebrae. As will beapparent to those skilled in the art, such sleeves can include virtuallyany device capable of releasably engaging and extending from a targetvertebra. For example, as shown in FIGS. 2A-2E, at least one of thesurgical sleeves 48 can be a percutaneous access device 48. In general,the percutaneous access device 48 can be any device having a distal end48 _(D) configured to releasably engage a bone anchor B₁, and having alength (l) such that a proximal end 48 _(P) of the percutaneous accessdevice 48 is accessible to a user. Also apparent to those skilled in theart, the bone anchor B₁ can include any element having a distal portion(not shown) configured to engage a vertebral bone V₁ (e.g., a threadedshank) and a proximal receiving head B_(P) that can be coupled to thedistal bone engaging element wherein the receiving head B_(P) isconfigured to receive a fixation element 50. Further, the receiving headB_(P) of the bone anchor B₁ can be configured to receive a closuremechanism (e.g., a set screw, a plug, or a pin) to secure the fixationelement within the receiving head B_(P). In an exemplary embodiment, thelength (l) of the device 48 is selected such that the proximal end 48_(P) of the percutaneous access device 48 is positioned external thepatient. Further, the percutaneous access device 48 can include an innerlumen extending from the proximal end 48 _(P) to the distal end 48 _(D)thereby providing a passageway for delivery of various instrumentsand/or elements (e.g., a fixation element) to the treatment site.

The system also includes a fulcrum that is configured to be movablycoupled to some component of the system such that the fulcrum can beeasily and reliably positioned at a desired location relative to theadjacent surgical sleeves. In general, the fulcrum can be any suchelement capable of performing the desired function. For example, FIG. 1Aand FIGS. 2A-2E provide an exemplary embodiment of such a fulcrum 14 inrelation to first and second surgical sleeves 48, 48′. As shown, thefulcrum 14 can be sized and configured as a cylinder or cylindrical-likeelement having a longitudinal axis (L′) extending therethrough. Also,the fulcrum 14 can have a diameter selected to provide the desiredamount of manipulation. In some embodiments, as shown in FIGS. 4A-4C,the diameter of the fulcrum 14 can be increased by coupling an insert 64to the fulcrum 14. The insert 64 can be coupled to the fulcrum 64 in anyof a number of ways. For example, referring to FIG. 4C, the insert 64can include a plurality of clips 66, 68, 70, 72 configured to releasablyengage the fulcrum 14. As will be apparent to those skilled in the art,virtually any element or mechanism capable of modifying the diameter ofthe fulcrum is within the spirit and scope of the presently disclosedsystem.

The system can be configured in various ways to allow the fulcrum to bequickly and accurately secured at any of a number of desired locationsrelative to the adjacent sleeves 48, 48′. In one such embodiment, thefulcrum 14 can be movably coupled to a manipulation device 10 which issized and configured to be positioned over a surgical sleeve 48extending from a vertebra. FIGS. 1A-1C provide an exemplary embodimentof a such manipulation device 10 which includes a proximal end 10 _(P),a distal end 10 _(D), and an inner lumen extending therebetween which issized and configured to receive the surgical sleeve 48.

Various embodiments of such a manipulation device 10 are providedherein. In the exemplary embodiment of FIGS. 1A-1C and FIGS. 2A-2E, themanipulation device 10 can include a length L₁ substantially identicalto the length (l) of the surgical sleeve 48 thereby allowing themanipulation device 10 to extend out of the patient's body from the boneanchor B₁. As shown in FIGS. 1A-1C, the distal portion 10 _(D) of themanipulation device 10 can include an indentation 12 configured toreceive (e.g., straddle) a fixation element 50 disposed within acorresponding bone anchor B₁ (also see FIGS. 2A-2E). Such an indentation12 can help to prevent slippage and/or twisting of the sleeve 10 duringany aspect of the procedure. Additionally, positioning the distal end 10_(D) of the manipulation device 10 over the location where thepercutaneous access device 48 engages the bone anchor B₁ can provideadded stability during the fixation procedure (e.g., thereby preventingthe surgical sleeve 48 from disengaging the bone anchor B₁).

FIGS. 3A-3B show an alternative exemplary embodiment wherein themanipulation device 10′ includes a proximal end 10′_(P) configured toengage (e.g., abut) a proximal end 48 _(P) of the surgical sleeve 48thereby resulting in the distal end 10′_(D) of the manipulation device10′ residing at a location proximal of the distal end 48 _(D) of thesurgical sleeve 48. Such an embodiment can be especially useful in thoseprocedures having adjacent surgical sleeves 48, 48′ extremely close toone another or even criss-crossing thereby making it difficult todeliver the distal end 10′_(D) of the manipulation device 10′ to thedistal end 48′_(D) of the surgical sleeve 48′. Like above, thisalternative embodiment can be configured in various ways to preventslipping and/or twisting during any step of the fixation procedure. Forexample, a proximal region 10′_(P) of the manipulation device 10′ caninclude at least one flat region 10′_(F) corresponding to a flat region48 _(F) formed on the proximal portion 48 _(P) of the surgical sleeve 48thereby preventing any undesired twisting of the manipulation device 10′relative to the surgical sleeve 48. It will be apparent to those skilledin the art that any such mechanism and/or configuration can be utilizedto prevent such unwanted movement.

The fulcrum 14 can be movably coupled to the manipulation device 10 invirtually any manner capable of allowing the fulcrum 14 to be moved(e.g., slid) from a first secure position to a second secure positionalong a length of the sleeve 10. In the exemplary embodiment of FIGS.1A-1C, the manipulation device 10 can include an engagement track 16extending along any desired length of the device 10. Further, theengagement track 16 can include any number of engagement points 18, 18′,etc. positioned along the length of the engagement track 16. Asdescribed below, the fulcrum 14 can be configured to releasably engageany such engagement point 18, 18′ to enable the fulcrum 14 to bepositioned at any desired location relative to a longitudinal axis (L)of the manipulation device 10. For example, to effect compression of aspinal construct, the fulcrum 14 can be positioned at a proximalposition of the engagement track 16 (see FIG. 2C) to allow for amanipulation device to be applied at a location below the fulcrum 14.Alternatively, to effect distraction (see FIG. 3B), the fulcrum 14 canbe positioned at a distal end of the engagement track 16 to allow themanipulation force to be applied at a location above the fulcrum 14.

The fulcrum 14 can be slidably coupled to the engagement track 16 invarious manners. For example, as shown in FIGS. 1B-1C, the fulcrum 14can include a first end 15 and a second end 16 wherein at least one end15, 16 includes an actuator 20, 20′ capable of releasing the fulcrum 14in response to an actuation force. While virtually any type of actuationmechanism can be utilized, in the illustrated exemplary embodiment, eachactuator 20, 20′ can be configured as a spring-biased button. In such anembodiment, the first and second actuators 20, 20′ are in an extendedposition (i.e., biased apart from one another) in the absence of anactuation force and configured to move to a retracted position inresponse to the actuation force. In the extended position, the actuators20, 20′ can be configured to securely engage an engagement point 18, 18′along the engagement track 16 thereby securing the fulcrum 14 at adesired location. However, in the retracted position (i.e., in thepresence of the actuation force), the actuators 20, 20′ can disengagethe engagement points 18, 18′ thereby allowing the fulcrum 14 to slidefrom a first position 18 to any other position 18′ of the engagementtrack 16.

As will be apparent to those skilled in the art, suchengagement/disengagement mechanisms can be provided in various manners.In the illustrated exemplary embodiment, the fulcrum 14 can include aslot 28 configured to receive the engagement track 16 such that thefulcrum 14 can slide along the track 16 (as indicated by up and downarrows in FIG. 1A). Further, the first actuator 20 can include a firstprotrusion 32 and the second actuator 20′ can include a secondprotrusion 32′. In the absence of an actuation force, the first andsecond protrusions 32, 32′ can reside within corresponding engagementpoints 18 (e.g., notches) of the engagement track 16 thereby securingthe fulcrum 14 at the desired location. During application of theactuation force, the first and second protrusions 32, 32′ can be movedout of the corresponding engagement points 18 thereby allowing thefulcrum 14 to once again slide along the length of the engagement track16. To provide stability, as illustrated in FIGS. 1B-1C, a first setscrew 24 can be placed in communication with the first actuator 20 and asecond set screw 24′ can be placed in communication with the secondactuator 20′ thereby contacting corresponding portions 30, 30′ of theactuator 20, 20′. Following manufacture, the proximal portion of eachset screw can be removed (e.g., by grinding). One skilled in the artwill appreciate that rather than being slidable in the track 16, thefulcrum can be removable from the track and repositionable at a desiredlocation.

In other embodiments of the system, the fulcrum can be repositionablerelative to adjacent surgical sleeves in various other ways. Forexample, FIGS. 5A-5C provide an alternative exemplary embodiment havinga fulcrum element 77 capable of being coupled to a proximal portion ofthe surgical sleeve 48. More specifically, the fulcrum element 77 caninclude a cap element 76 sized and configured to be positioned over theproximal end of the sleeve 48. The cap 76 can also include a flat 76_(F) corresponding to a flat region of the surgical sleeve 48 therebypreventing any unwanted movement (e.g., twisting) during any step of theprocedure. As shown in FIGS. 5B-5C, the cap 76 can be configured toreleasably engage a fulcrum 78 by inserting an extension 80 of thefulcrum 78 into a corresponding receiving element 82 formed on the cap82 (or vice versa). In other embodiments, the cap 76 and the fulcrum 78can be a single component. Like above, this embodiment can allow for thefulcrum 78 to be positioned at any desired position relative to adjacentsurgical sleeves 48, 48′. For example, the surgeon can have a pluralityof such caps (e.g., a kit) wherein each cap can have a distinct lengththereby allowing the fulcrum 78 to be positioned at any number oflocations relative to the adjacent sleeves 48, 48′. In anotherembodiment (not shown), a single cap can be provided which includes aplurality of extensions along a length thereof thereby allowing thefulcrum to engage any of the extensions thereof. Additionally, fulcrums78 of various diameters can also be provided in order to allow for thedesired therapeutic result. Those skilled in the art will appreciatethat various other embodiments of engaging the fulcrum along the lengthof the surgical sleeve can be included within the presently disclosedsystem. For instance, the surgical sleeve can include a series ofopenings (not shown) along the length of the device wherein a fulcrumcan be configured to slide between the openings and/or be engaged anddisengaged from any of the openings.

In yet another exemplary embodiment, the fulcrum can be movably coupledto a driver thereby allowing the surgeon to easily control the positionof the fulcrum relative to the application of the manipulation force onadjacent surgical sleeves. The fulcrum can be movably coupled in anymanner to any type of driver. For example, FIGS. 6A-6C provide anexemplary embodiment wherein a driver 60′ is a forceps-like instrumenthaving a first extension 52 configured to contact a first surgicalsleeve and a second extension 54 configured to contact a second surgicalsleeve thereby allowing a manipulation force to be applied to theadjacent sleeves. In such an embodiment, the driver 60′ can include afulcrum 92 coupled thereto such that the fulcrum 92 can be moved betweenan extended orientation (as shown in FIG. 6A) or a retracted orientation(as shown in FIG. 6B). In the extended orientation, the fulcrum 92 isbelow the point at which the manipulation force is applied therebyresulting in distraction of a spinal construct. In the retractedposition, the fulcrum 92 can be positioned above the point at which themanipulation force is applied thereby resulting in a compression of thespinal construct.

While the fulcrum 92 can be engaged to the driver 60′ in virtually anymanner capable of allowing the desired movement, FIG. 6C provides anexemplary embodiment which includes an elongate member 94 extendingproximally from the fulcrum 92 and having a central channel 96 extendingalong a length of the member 94. A locking element 100 can be configuredto pass through the central channel 96 so as to lock or release theelongate member relative to the driver 60′. Optionally, a plurality ofridges 102 or other type(s) of roughened regions can be incorporatedinto the elongate member 94 thereby further securing the fulcrum 92 atthe desired location.

Additionally, the present disclosure also includes various embodimentsof a method of manipulating (e.g., distracting or compressing) a spinalconstruct. In any such embodiment, the method can include repositioninga fulcrum relative to adjacent surgical sleeves thereby allowing thedesired manipulation force to be supplied to the sleeves at a locationabove or below the fulcrum. Various embodiments of the method canutilize any of the embodiments of the system described above such that,for example, the fulcrum can be movably coupled to a manipulationdevice, the fulcrum can be movably coupled to the surgical sleeve, thefulcrum can be movably coupled to a driver, etc. Additionally, themethods disclosed herein can be performed as a minimally invasiveprocedure or as an open procedure.

FIGS. 2A-2E provide an exemplary embodiment of a method for effectingcompression of a spinal construct. As shown in FIG. 2A, the method caninclude engaging a first bone anchor B₁ to a first vertebra V₁, andengaging a second bone anchor B₂ to a second vertebra V₂ which isadjacent the first vertebra V₁. As will be apparent to those skilled inthe art, various embodiments can utilize any number of bone anchors B₁,B₂, B₃, etc. along any length of a patient's spinal column. As describedbelow, the use of numerous such sleeves can provide for compressionand/or distraction of any number of spinal constructs along any lengthof a patient's spinal column.

While any of the above-described embodiments of the system can beutilized in the presently disclosed method, FIGS. 2A-2E illustrate theuse of a manipulation device 10 having a fulcrum 14 movably (e.g.,slidably) coupled thereto. Referring to FIGS. 2A and 2B, themanipulation device 10 can be sized and configured to receive a firstsurgical sleeve 48 therethrough. Also shown, a second accessory sleeve34 can optionally be positioned over a second surgical sleeve 48′. Aswill be apparent to those skilled in the art, the second accessorysleeve 34 can be any of a wide range of such accessory sleeves capableof providing various therapeutic benefits. For example, as shown, theaccessory sleeve 34 can be an anti-torque sleeve 34 which can include ahandle element 36 extending therefrom. As described, the anti-torquesleeve 34 can allow the surgeon to quickly deliver a closure mechanism(not shown) to the second bone anchor immediately following compressionor distraction of the spinal construct (C) thereby securing the fixationelement 50 in the desired location. While a wide range of suchanti-torque sleeves 34 can be utilized, in this exemplary embodiment,the anti-torque sleeve 34 includes a proximal end, a distal end, and aninner lumen extending therebetween that is sized and configured toreceive the second surgical sleeve 48′.

Referring to FIG. 2C, the method can further include determining adesired location for positioning of the fulcrum relative to the adjacentsurgical sleeves 48, 48′, and subsequently releasably engaging thefulcrum 14 at the location. While the fulcrum 14 can be positionedanywhere along the sleeve 10, in a compression procedure, the surgeonwill typically prefer to position the fulcrum 14 as high as possiblealong the sleeve 10. In such a position, a manipulation instrument 60can easily provide the desired compression force (F_(C)) at a locationbelow the fulcrum 14 thereby providing an optimal amount of force to thefirst and second surgical sleeves 48, 48′ (as shown in FIGS. 2D-2E).Once complete, a second closure mechanism (not shown) can be secured tothe second bone anchor thereby securing the spinal fixation element 50within the second bone anchor and serving to maintain the effectedamount of compression. As indicated above, use of the anti-torque sleeve34 can allow the surgeon to immediately secure (e.g., tighten or lock)the second closure mechanism thereby preventing any loss of compressionthat could result from any delay.

In an alternative embodiment, as shown in FIGS. 3A-3B, the method caneffect distraction of a spinal construct. In such a procedure, thesurgeon will typically prefer to releasably engage the fulcrum 14 as lowon the sleeve 10′ as possible (i.e., as close to the target spinalconstruct (C′) as possible) thereby providing the optimal distractionforce (F_(D)) as the distraction force is applied above the fulcrum 14.Thus, as shown in FIG. 3B, the distraction force (F_(D)) can be appliedabove the fulcrum 14 thereby distracting the construct C′ the desiredamount. While an anti-torque sleeve is not shown in FIG. 3B, it will beapparent to those skilled in the art that such a sleeve could bepositioned over the second percutaneous access device thereby allowingthe surgeon to secure a closure mechanism to the second bone anchorimmediately following the desired distraction.

The exemplary embodiments provided above illustrate compression ordistraction of a single spinal construct. However, as will be apparentto one skilled in the art, the method can include further includeeffecting compression and/or distraction to any number of vertebraealong any desired length of the patient's spine. For example, in thoseembodiments utilizing a manipulation device, following compression ordistraction of a single spinal construct, the method can includeremoving the manipulation device from the first surgical sleeve andreplacing the anti-torque sleeve (if used) from the second surgicalsleeve with the manipulation device. In such an embodiment, theanti-torque sleeve can then be repositioned over a third such surgicalsleeve extending from a third vertebra wherein the third vertebra isadjacent the second vertebra. Once positioned as such, the manipulationdevice can be utilized to deliver a second manipulation force to themanipulation device and the anti-torque sleeve thereby once againeffecting a desired compression or distraction upon the second spinalconstruct. Following the desired manipulation, like above, a thirdclosure mechanism can be secured to the third bone screw thereby onceagain securing the fixation element within the third bone anchor. Aswill be apparent to those skilled in the art, all or at least some ofthese steps can be repeated as many times as desired so as to effectcompression and/or distraction of any number of spinal constructsextending along the patient's spinal column.

One skilled in the art will appreciate further features and advantagesof the presently disclosed system and method based on theabove-described embodiments. Accordingly, the present disclosure is notto be limited by what has been particularly shown and described, exceptas indicated by the appended claims. All publications and referencescited herein are expressly incorporated herein by reference in theirentirety.

What is claimed is:
 1. A spinal manipulation system, comprising: apercutaneous access device having a proximal end, a distal end, and aninner lumen extending therebetween, the distal end being configured toengage a bone anchor; a sleeve configured to be positioned over theproximal end of the percutaneous access device; a fulcrum releasablycoupled to a mating element on the sleeve such that the fulcrum can beselectively positioned at a desired level on the sleeve.
 2. The systemof claim 1, wherein the distal end of the sleeve includes an indentationformed in the outer surface of the sleeve, the indentation configured toreceive a spinal fixation element.
 3. The system of claim 1, wherein theproximal end of the sleeve is configured to releasably engage a proximalend of the percutaneous access device.
 4. The system of claim 3, whereinthe proximal end of the sleeve further includes at least one flat regioncorresponding to a flat region formed on the proximal end of thepercutaneous access device.
 5. The system of claim 1, wherein the matingelement is one of a plurality of engagement points along a length of thesleeve for releasably engaging the fulcrum.
 6. The system of claim 1,further comprising plurality of inserts configured to be coupled to thefulcrum to increase the diameter of the fulcrum.
 7. The system of claim1, further comprising: an anti-torque sleeve having a proximal end, adistal end, and an inner lumen extending therebetween, the anti-torquesleeve sized and configured to receive a second percutaneous accessdevice.
 8. A spinal manipulation system, comprising: a sleeve having aproximal end, a distal end, and an inner lumen extending therebetween;and a fulcrum releasably coupled to the sleeve such that the fulcrum canbe selectively positioned at a desired level on the sleeve, wherein thefulcrum is releasably engaged to a mating element on a cap that isconfigured to be positioned over a proximal end of the sleeve.
 9. Aspinal manipulation system, comprising: a first surgical sleeveconfigured to engage a first vertebrae; a second surgical sleeveconfigured to engage a second vertebrae; a driver configured tosimultaneously supply a manipulation force to the first and secondsurgical sleeves to effect at least one of compression and distractionof the first and second vertebra; and a fulcrum longitudinally movablycoupled to any one of the first surgical sleeve, the second surgicalsleeve, or the driver via a mating feature such that the fulcrum can beselectively positioned at a desired level relative to the first andsecond surgical sleeves and the driver.
 10. The system of claim 9,wherein the fulcrum is movably coupled to the driver.
 11. The system ofclaim 9, wherein the fulcrum is coupled to a cap that is configured tobe positioned over a proximal end of the first surgical sleeve.
 12. Thesystem of claim 9, further comprising: a manipulation device having aproximal end, a distal end, and an inner lumen extending therebetweenthat is sized and configured to receive the first surgical sleeve, themating feature comprising a plurality of engagement points extendingalong a length of the manipulation device, the engagement points beingconfigured to releasably engage the fulcrum.
 13. The system of claim 9,further comprising: an anti-torque sleeve having a proximal end, adistal end, and an inner lumen extending therebetween that is sized andconfigured to receive the second surgical sleeve.
 14. A spinalmanipulation system, comprising: a percutaneous access device having aproximal end and a distal end, the distal end of the percutaneous accessdevice being configured to engage a bone anchor; a manipulation devicehaving a proximal end, a distal end, and an inner lumen extendingtherebetween that is sized and configured to be positioned over thepercutaneous access device; an engagement track extending along at leasta portion of a length of the manipulation device that includes at leastone engagement point formed along a length of the engagement track; anda fulcrum having a mating feature that slidably couples to theengagement track, the mating feature being configured to releasablyengage the at least one engagement point.
 15. The system of claim 14,wherein the fulcrum is a substantially cylindrical element having firstand second ends with a longitudinal axis extending between the ends, thefulcrum configured to be coupled to the manipulation device such thatthe longitudinal axis of the fulcrum is perpendicular to a longitudinalaxis of the percutaneous access device.
 16. The system of claim 15,wherein the fulcrum includes a first actuator coupled to the first endand a second actuator coupled to the second end, the first and secondactuators being spring biased such that in the absence of an actuationforce the fulcrum can remain securely engaged to a desired engagementpoint.